Transfusion of plasma to prevent bleeding in ICU patients.

Completed

• Conditions: Fresh frozen plasmaCoagulopathyIntensive CareAdverse effectsDutch:PlasmaStollingsstoornissenIntensive CareBijwerkingen

• Registration Number: NL-OMON27877
• Lead Sponsor: Academic Medical Center, Amsterdam, The Netherlands

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

1. Patients admitted to the ICU of 18 years and older;

2. INR >1,5 and <3,0;

Exclusion Criteria

1. Clinically overt bleeding at the time of the procedure;

2. Thrombocytopenia <30*109/L;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of this study will be a procedure related relevant bleeding, occurring within 24 hours after the procedure.

Secondary Outcome Measures

Name	Time	Method
1. Minor bleeding within 24 hours of the intervention;<br /><br>2. Onset of acute lung injury within 48 hours;<br /><br>3. Correction of INR to <1,5 (after the transfusion of FFP and before the procedure, only in the transfusion arm);<br /><br>4. Correction of coagulation variables;<br /><br>5. Length of ventilation days;<br /><br>6. Length of ICU stay;<br /><br>7. ICU mortality;<br /><br>8. Serious adverse events.